Longitudinal (Weekly) Follow-up of Active Plaques in Multiple Sclerosis With 3 Teslas Multi-modality MRI Using Diffusion, Perfusion, Venography and Proton Spectroscopy

NCT00861172 | Completed DMC

• 1 other identifier: 2008.532
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

It is difficult to determinate prognostic criteria of Multiple Sclerosis with conventional MRI insofar as physiopathology is not well-known: the precise sequences of events leading to plaque formation and axonal injury are still not completely understood. Some elements involved in plaque formation can be studied thanks to MR techniques (cerebrospinal fluid and periveinular spaces, neuronal injury, microglia, and cerebral microcirculation's dysfunction). This study aims at giving a better understanding of MS plaques' physiopathology, using data from modern MRI through a longitudinal followed up with weakly MR 3T examination.

Conditions

Lesions; Multiple Sclerosis

Keywords

Multiple sclerosis; Active plaque; Multimodal analysis; 3T MRI; Weekly follow-up; Physiopathology; Physiopathology of active lesions formation in Multiple Sclerosis using multimodal MR sequences

Outcome Measures

Primary Outcomes (1)

• Modification of MR parameters before and after the blood brain barrier disruption observed in newly enhancing lesion in MS.

  each week for 2 months, at 6 month and at 12 month

Secondary Outcomes (2)

• Predictive scorers of plaque transformation in "black-holes", which correspond with a pejorative evolution of accurate lesions, also defined by a focal destruction of cerebral tissue.

  each week for 2 months, at 6 month and at 12 month

• Relation between plaques development and cerebral venous structures.

  each week for 2 months, at 6 month and at 12 month

Study Arms (1)

1

EXPERIMENTAL

Procedure: 3T MR scanner

Interventions

3T MR scanner PROCEDURE

The follow-up will be scheduled for one year; it will consist in a weekly MR examination during the first two months, and subsequently on the 6th and the 12th months. We will perform for each MRI exploration an intravenous injection of contrast agents: gadobutrol (gadovist 1,0 mmol/ml) which is a stable agent with a cyclic structure. This agent is few responsible for NFS, given their low capacity to liberate gadolinium GD3+ in tissues. The same imaging protocol will be performed for each MR examination. Evaluation of creatinemia will be used before inclusion and during the 1st, 3rd, 5th, 7th, 9th, and the 10th MRI examination. Thus we will take advantage of catheter to perform the creatinemia blood test and to reduce the discomfort produced by the injection.

1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 50 years.
• Health coverage.
• Any form of MS defined by Mc Donald's criteria (2005).
• Patients having shown an enhanced plaque on a less than six month MRI examination.

You may not qualify if:

• Patients with an immunomodulating therapy like natalizumab (Tysabri) and intravenous immunosuppressive therapies. Other therapies will not be excluded from this study. For patients treated by systemic corticotherapy, a one-month delay will be necessary before a MRI examination.
• Cerebral microangiopathy (diabetes, arterial hypertension, vascularitis…)
• Patient with classical MRI contraindication like pace-maker, cardiac valvulosis, claustrophobia, allergy to contrast agent …
• Pregnancy or pregnancy desire.
• Patient with a low creatinine clearance \<60 ml/mn

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Services de Neurologie A et Service de Neuroradiologie, Pôle transversal d'imagerie, Hôpital Neurologique

Bron, 69677, France

Location

Related Publications (1)

• Hannoun S, Roch JA, Durand-Dubief F, Vukusic S, Sappey-Marinier D, Guttmann CR, Cotton F. Weekly multimodal MRI follow-up of two multiple sclerosis active lesions presenting a transient decrease in ADC. Brain Behav. 2015 Feb;5(2):e00307. doi: 10.1002/brb3.307. Epub 2015 Jan 16.

  PMID: 25642392 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Francois Cotton, Pr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 13, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: June 21, 2013

Record last verified: 2013-06

Locations

FR (1)